Peripheral Subcutaneous Field Stimulation

Peripheral Subcutaneous Field Stimulation Policy Number: 7.01.139 Last Review: 3/2018 Origination: 7/2013 Next Review: 9/2018 Policy Blue Cross and Blue Shield of Kansas City (Blue KC) will not provide coverage for peripheral subcutaneous field stimulation. This is considered investigational. Please note that this is a type of electrical stimulation that is considered a benefit exclusion in many health plan contracts. When Policy Topic is covered Not Applicable When Policy Topic is not covered Peripheral subcutaneous field stimulation is investigational. Description of Procedure or Service Populations Interventions Comparators Outcomes Individuals: With chronic neuropathic pain Interventions of interest are: Peripheral subcutaneous field stimulation Comparators of interest are: Medication Exercise, physical therapy Cognitive-behavioral therapy Relevant outcomes include: Symptoms Functional outcomes Quality of life Treatment-related morbidity Peripheral subcutaneous field stimulation (PSFS) is a form of neuromodulation intended to treat chronic neuropathic pain. Applications of PSFS being evaluated are craniofacial stimulation for headache/migraine, craniofacial pain, or occipital neuralgia. PSFS is also being investigated for low back pain, neck and shoulder pain, inguinal and pelvic pain, thoracic pain, abdominal pain, fibromyalgia, and postherpetic neuralgia. For individuals who have chronic neuropathic pain who receive PSFS, the evidence includes 1 randomized controlled trial (RCT), 1 nonrandomized comparative study, and case series. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. The single RCT, which used a crossover design, did not compare PSFS to alternatives. Rather, it compared different

methods of PSFS. Among trial participants, 24 (80%) of 30 patients had at least a 50% reduction in pain with any type of PSFS. However, because the RCT did not include a sham group or comparator with a different active intervention, this trial offers little evidence for efficacy beyond that of a prospective, uncontrolled study. Case series are insufficient to evaluate patient outcomes due to the variable nature of pain and the subjective nature of pain outcome measures. Prospective controlled trials comparing PSFS with placebo or alternative treatment modalities are needed to determine the efficacy of PSFS for chronic pain. The evidence is insufficient to determine the effects of the technology on health outcomes. Background Chronic Pain Chronic, noncancer pain is responsible for a high burden of illness. Common types of chronic pain are lumbar and cervical back pain, chronic headaches, and abdominal pain. All of these conditions can be challenging to treat. Treatment Pharmacologic agents are typically the first-line treatment for chronic pain, and several classes of medications are available. They include analgesics (opioid and nonopioid), antidepressants, anticonvulsants, and muscle relaxants. A variety of nonpharmacologic treatments also exist, including physical therapy, exercise, cognitive-behavioral interventions, acupuncture, chiropractic, and therapeutic massage. Neuromodulation, a form of nonpharmacologic therapy, is usually targeted toward patients with chronic pain refractory to other modalities. Some forms of neuromodulation, such as transcutaneous electrical nerve stimulation and spinal cord stimulation (SCS), are established methods of chronic pain treatment. Peripheral nerve stimulation, which involves placement of an electrical stimulator on a peripheral nerve, is also used for neuropathic pain originating from peripheral nerves. Peripheral Subcutaneous Field Stimulation Peripheral subcutaneous field stimulation (PSFS) is a modification of peripheral nerve stimulation. In PSFS, leads are placed subcutaneously within the area of maximal pain. The objective of PSFS is to stimulate the region of affected nerves, cutaneous afferents, or the dermatomal distribution of the nerves, which then converge back on the spinal cord. Combination SCS plus PSFS is also being evaluated. Similar to SCS or peripheral nerve stimulation, permanent implantation is preceded by a trial of percutaneous stimulation with at least 50% pain reduction. Currently, there is no consensus on the indications for PSFS. Criteria for a trial of PSFS may include a clearly defined, discrete focal area of pain with a neuropathic or combined somatic/neuropathic pain component with characteristics of burning and increased sensitivity, and failure to respond to other conservative treatments including medications, psychological therapies, physical therapies, surgery, and pain management programs.

The mechanism of action in PSFS is unknown. Theories include an increase in endogenous endorphins and other opiate-like substances; modulation of smaller A delta and C nerve fibers by stimulated large-diameter A beta fibers; local stimulation of nerve endings in the skin; local anti-inflammatory and membranedepolarizing effect; or a central action via antegrade activation of A beta nerve fibers. Complications of PSFS include lead migration or breakage and infection of the lead or neurostimulator. Regulatory Status No devices have been approved by the U.S. Food and Drug Administration (FDA) specifically for peripheral subcutaneous field stimulation (PSFS). PSFS is an offlabel use of spinal cord stimulation devices that have been approved by FDA for the treatment of chronic pain. Rationale This evidence review was originally created in March 2013, and has been updated regularly with searches of the MEDLINE database. The most recent literature review covered the period through February 23, 2017. Case series provide limited evidence for the efficacy of pain treatments due to the variable nature of pain and the subjective nature of pain outcome measures. Randomized controlled trials (RCTs) with adequate blinding are needed to control for the variable natural history of pain and for the expected placebo effect in research on pain treatment; therefore, we focused our literature review on RCTs with blinded outcome measures. Chronic Neuropathic Pain No sham- or active pain treatment-controlled RCTs evaluating peripheral subcutaneous field stimulation (PSFS) were identified. One crossover RCT compared levels of PSFS stimulation. McRoberts et al (2013) reported on a randomized, crossover trial of different types of PSFS in 44 patients with chronic back pain. In the first phase of the trial, patients rotated through 4 levels of trial PSFS: minimal, subthreshold, low frequency, and standard stimulation. 1 Of 30 patients who completed the first phase, 24 reported that pain was significantly reduced by at least 50% in any of the stimulation groups and were considered responders to PSFS. In phase 2, a permanent PSFS system was placed in 23 responders. During the 52 weeks over which these patients were followed, reported mean visual analog scale (VAS) scores, present pain index, and total scores on the Short-Form McGill Pain Questionnaire were significantly improved from baseline at all follow-up visits (p<0.001). Because this trial did not include a control group, the methodologic strength of these results is similar to that of an uncontrolled study. Another comparative study used a 2-part comparative evaluation of combined use of spinal cord stimulation (SCS) and PSFS in patients with low back pain; it was reported by Mironer et al in 2011. 2 In the first part of the study, 20 patients with

failed back surgery syndrome or spinal stenosis underwent a trial with both SCS and PSFS and selected the type of stimulation they found most efficacious (program 1: SCS alone; program 2: PSFS alone; program 3: combined SCS and PSFS). Patients were blinded to the differences among the programs (randomized order of presentation) and were encouraged to try each program for at least 8 hours; 79% percent of patients preferred the simultaneous use of SCS and PSFS. In the second part of the study, 20 patients were implanted with SCS and PSFS electrodes and selected which program they preferred (SCS and PSFS used simultaneously, SCS as anode and PSFS as cathode, SCS as cathode and PSFS as anode). The programs were presented in a random order, and patients were blinded to the differences among the programs offered. Communication between SCS and PSFS was reported to provide wider coverage of axial pain, with an overall success rate (>50% pain relief) of 90%. The most effective program was SCS as cathode and PSFS as anode. In addition to the controlled studies, a number of case series have been published, several of which included 50 or more patients. In 2014, Kloimstein et al reported on a prospective multicenter study of 118 patients treated with PSFS for chronic low back pain. 3 Before patients were implanted with the permanent PSFS system, trial stimulation was given for at least 7 days. The permanent stimulation system was implanted in 105 patients. Significant improvements occurred at the 1-, 3-, and 6-month follow-ups after implantation in average pain VAS, Oswestry Disability Questionnaire, Beck Depression Inventory, and 12-Item Short-Form Health Survey scores. Significant reductions in use of opioid, nonsteroidal antiinflammatory, and anticonvulsant medications were also reported. Sator-Katzenschlager et al (2010) reported on a retrospective multicenter study of PSFS. 4 A total of 111 patients with chronic focal noncancer pain were treated, including 29 patients with low back pain, 37 with failed back surgery syndrome, 15 with cervical neck pain, and 12 patients with postherpetic neuralgia. The median duration of chronic pain was 13 years, and the median number of previous surgeries was 2.7. For permanent implantation of the leads, patients had to have achieved at least 50% reduction in pain on a numeric rating scale during the trial period. After permanent implantation, pain intensity decreased in 102 (92%) patients. Mean pain intensity decreased from 8.2 at baseline to 4.0 at follow-up, with a concomitant reduction in consumption for analgesics and antidepressants. Lead dislocation or fracture occurred in 20 (18%) patients. In 2011, Verrills et al reported on a series of 100 patients treated with PSFS for chronic neuropathic pain. Indications included chronic pain occurring among varying regions: occipital/craniofacial (n=40), lumbosacral (n=44), thoracic (n=8), groin/pelvis (n=5), or abdominal (n=3). 5 Selection criteria included a clearly defined, discrete focal area of pain with a neuropathic component or combined somatic/neuropathic pain component with characteristics of burning and increased sensitivity, and failure to respond to other conservative treatments, including medications, psychological therapies, physical therapies, surgery, and pain management programs. Outcomes, assessed at a mean of 8.1 months after implantation (range, 1-23 months), included a combination of numeric pain

scores, self-report questionnaires, and patient medical histories. For the entire cohort, pain decreased from 7.4 at baseline to 4.2 at follow-up. Pain scores improved by 75% or more in 34% of patients and by 50% or more in 69% of patients. Analgesia use decreased in 40% of patients after PSFS. Adverse events were reported in 14% of patients and included unpleasant sensations, lead erosions, and lead or battery migration. In 2014, Verrills et al reported on PSFS for chronic headache conditions. 6 After a trial stimulation period, 60 patients underwent permanent implantation of the PSFS system and were followed for an average of 12.9 months (range, 3-42 months). Ten patients required revision of the implant system. Significant reductions in pain from baseline were reported (p 0.001). Additionally, use of analgesics or prophylactic medications was reduced in 83% of patients, and reductions in degree of disability and depression were noted. Summary of Evidence For individuals who have chronic neuropathic pain who receive peripheral subcutaneous field stimulation (PSFS), the evidence includes 1 randomized controlled trial (RCT), 1 nonrandomized comparative study, and case series. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. The single RCT, which used a crossover design, did not compare PSFS to alternatives. Rather, it compared different methods of PSFS. Among trial participants, 24 (80%) of 30 patients had at least a 50% reduction in pain with any type of PSFS. However, because the RCT did not include a sham group or comparator with a different active intervention, this trial offers little evidence for efficacy beyond that of a prospective, uncontrolled study. Case series are insufficient to evaluate patient outcomes due to the variable nature of pain and the subjective nature of pain outcome measures. Prospective controlled trials comparing PSFS with placebo or alternative treatment modalities are needed to determine the efficacy of PSFS for chronic pain. The evidence is insufficient to determine the effects of the technology on health outcomes. Supplemental Information Practice Guidelines and Position Statements In 2013 the National Institute for Health and Care Excellence issued guidance on peripheral subcutaneous field stimulation for chronic low back pain. 7 The guidance stated: Current evidence on the efficacy of peripheral nerve-field stimulation (PNFS) for chronic low back pain is limited in both quantity and quality, and duration of follow-up is limited. Evidence on safety is also limited and there is a risk of complications from any implanted device. Therefore this procedure should only be used with special arrangements for clinical governance, consent and audit or research. U.S. Preventive Services Task Force Recommendations Not applicable.

Medicare National Coverage There is no national coverage determination (NCD). In the absence of an NCD, coverage decisions are left to the discretion of local Medicare carriers. Ongoing and Unpublished Clinical Trials Some currently unpublished trials that might influence this review are listed in Table 1. Table 1. Summary of Key Trials NCT No. Trial Name Planned Enrollment Ongoing ISRCTN53432663 A randomised, patient-assessor blinded, shamcontrolled trial of external non-invasive peripheral nerve stimulation for chronic neuropathic pain following peripheral nerve injury (EN-PENS trial NCT02893267 Multimodal Treatment for Hemiplegic Shoulder Pain NCT: national clinical trial: ISRCTN: International Standard RCT Number. Completion Date 75 Aug 2019 132 Dec 2021 References 1. McRoberts WP, Wolkowitz R, Meyer DJ, et al. Peripheral nerve field stimulation for the management of localized chronic intractable back pain: results from a randomized controlled study. Neuromodulation. Nov 2013;16(6):565-575. PMID 23577773 2. Mironer YE, Hutcheson JK, Satterthwaite JR, et al. Prospective, two-part study of the interaction between spinal cord stimulation and peripheral nerve field stimulation in patients with low back pain: development of a new spinal-peripheral neurostimulation method. Neuromodulation. Mar- Apr 2011;14(2):151-154; discussion 155. PMID 21992203 3. Kloimstein H, Likar R, Kern M, et al. Peripheral nerve field stimulation (PNFS) in chronic low back pain: a prospective multicenter study. Neuromodulation. Feb 2014;17(2):180-187. PMID 24320718 4. Sator-Katzenschlager S, Fiala K, Kress HG, et al. Subcutaneous target stimulation (STS) in chronic noncancer pain: a nationwide retrospective study. Pain Pract. Jul-Aug 2010;10(4):279-286. PMID 20230450 5. Verrills P, Vivian D, Mitchell B, et al. Peripheral nerve field stimulation for chronic pain: 100 cases and review of the literature. Pain Med. Sep 2011;12(9):1395-1405. PMID 21812906 6. Verrills P, Rose R, Mitchell B, et al. Peripheral nerve field stimulation for chronic headache: 60 cases and long-term follow-up. Neuromodulation. Jan 2014;17(1):54-59. PMID 24165152 7. National Institute for Health and Care Excellence (NICE). Peripheral nerve-field stimulation for chronic low back pain: guidance [IPG451]. 2013; https://www.nice.org.uk/guidance/ipg451. Accessed March 3, 2017. Billing Coding/Physician Documentation Information 64999 Unlisted procedure, nervous system Codes 0282T, 0283T, 0284T, 0285T were deleted 1/1/2017. Additional Policy Key Words N/A

Policy Implementation/Update Information 7/1/13 New policy; considered investigational. 1/1/14 No policy statement changes. 9/1/14 No policy statement changes. 3/1/15 No policy statement changes. 5/1/15 No policy statement changes. 9/1/15 No policy statement changes. 3/1/16 No policy statement changes. 9/1/16 No policy statement changes. 3/1/17 CPT codes updated. No policy statement changes. 9/1/17 No policy statement changes. 3/1/18 No policy statement changes. State and Federal mandates and health plan contract language, including specific provisions/exclusions, take precedence over Medical Policy and must be considered first in determining eligibility for coverage. The medical policies contained herein are for informational purposes. The medical policies do not constitute medical advice or medical care. Treating health care providers are independent contractors and are neither employees nor agents Blue KC and are solely responsible for diagnosis, treatment and medical advice. No part of this publication may be reproduced, stored in a retrieval system or transmitted, in any form or by any means, electronic, photocopying, or otherwise, without permission from Blue KC.